1. Field of the Invention
The current invention is related to the field of medical devices used for medical exams related to the feminine genital organ and, more precisely, reference is made to a device to perform an examination called Multidetector computed tomography virtual hysterosalpingography that allows for the use of digital technology to take images and avoid traumatic manipulations to which the patient is submitted with radiologic technologies and associated devices that are currently being used.
2. Description of the Prior Art
Before starting off with the description of the devices and systems that are currently known in the art and used to assist while performing medical exams such as the one related to the current invention, more particularly, Computed Tomography Virtual Hysterosalpingography, also known as Computed Tomography Histogram; Computed Tomography Uterosalpingography; Computed Tomography Uterotubography, it is necessary to at least generally reference this examination which will facilitate understanding of the object and content of the invention.
The computed tomography hysterosalpingography is an examination that allows for the tomographic visualization of the uterine cavity and the tubes, which is performed via the introduction of a radiopaque contrast liquid, diluted to 80% through the uterine cervix. This test is particularly indicated for sterility and fertility studies, in other words all disorders that lead to lack of conception and failure of pregnancies. This visualization provides information about the uterine and tubal cavities, such as the size, shape, position and potential pathologies. The examination also allows us to determine whether the uterine tubes are obstructed. The big difference with the conventional format (conventional or traditional hysterosalpingography) is that the virtual examination by computed tomography provides bidimensional, tridimensional and virtual endoscopic information which allows for a more precise diagnose. It does not only assess the uterine cavity but also the wall and external morphology of the uterus as well as visualize the pelvis as a whole, hereby allowing for the identification of adnexal and extra-gynaecological pathologies that may be associated.
In order to perform the conventional hysterosalpingography procedure, the patient is placed in the gynaecological position and before asepsis of the perineum a sufficiently lubricated speculum is placed to gain access to the cervix, after which the speculum is fixed in its position. Next, the vagina is cleaned and disinfected and a Risolia metallic cannula which in turn has a metal olive at its extremity which puts pressure on the external cervical orifice in order to occlude it and avoid reflux of the contrast fluid which is introduced a couple of millimeters inside the cervix. The cervix is taken at 12 o'clock from the exterior with a metallic forceps (Erina forceps) that was specifically designed for this purpose. The forceps and the cannula are immediately and simultaneously tractioned to deploy the uterine cervix in order to take the images. In other words, the uterine cervix, which generally contains curves that do not allow for complete or clear images to be taken, is straightened. This item is particularly important for the trauma that is caused to the patient, using a forceps that grabs the cervix, not only because it causes discomfort, in the best of cases, but also because it can be painful and causes small wounds with corresponding bleeding and/or additional infections.
Once the cervix has been tractioned with the cannula in its interior, the contrast liquid is injected and the area is irradiated to take the radiological images. Generally, oblique and lateral images are taken in order to show the entire uterus, the tubes and the passage of the contrast fluid to the peritoneum. This implies that the patient must change position during the taking of the images. Afterwards the instruments are withdrawn, the area is evacuated and sedatives and sometimes antibiotics are recommended.
This procedure is deficient because of at least three significant disadvantages. One is that it is considerably time-consuming, at times up to 40 minutes, which only increase the traumatic experience for the patient. Another disadvantage is that the cannula, grasper, connections of the cannula with the source of the liquid and the manual handles for the injection of the liquid into the uterus should be held and manipulated by professional staff that must stay with the patient almost constantly, whereby they are almost always exposed to X-radiation. Finally, the other disadvantage is that it only provides information about the interior of the organs (cervix, uterus and tubes), a “luminogram”, without giving information about the wall or their external morphology.
Considering the current state of the art available for the realization of medical exams such as the one mentioned previously, it would be very convenient to have a new technology to perform these exams in a shorter time span, without the need for continued assistance of medical personnel and without causing (or reducing to a minimum) any traumatic manipulations on the patient's body parts, while at the same time obtaining clearer images, with increased anatomic detail and with the additional possibility of using digital imagery techniques by means of modern instruments that use a reduced dose of X-radiation.